Percutaneous Closure Device Controlled INCRAFT Stentgraft Implantation Registry (PUCCINI).

Abstract

Background: Percutaneous endovascular repair (PEVAR) of infra-renal abdominal aortic aneurysms (AAA) is increasingly being performed due to the development of low profile endografts and the use of percutaneous closure devices. The feasibility and safety of the use of the INCRAFT AAA Stentgraft System and the ProGlide vascular closure system was assessed.

Methods: The PUCCINI trial prospectively enrolled patients undergoing elective repair of infrarenal AAA at 3 centres in the Netherlands and 3 centres in Belgium. Patients underwent PEVAR with endograft implantation followed by closure using the ProGlide closure device. Procedural success rates, complications and 30-day follow-up outcomes were collected.

Results: A total of 93 patients, 87% male, were enrolled. The mean aneurysmal diameter was 53.9 ± 10.2 mm. Successful ProGlide placement was achieved in 97.2% in the right and 89.8% in the left groin. Successful closure was achieved in 92.4% of right and 90% of left groins. One patient required surgical access and two surgical closure. Average blood loss was 155.6 ± 175.5ml. Blood transfusion was not required. Average length of hospital stay was 2.1 ± 1.3 days. Post-implantation endoleaks were present in 37 (40.2%) patients (type 1: 12, type 2: 25). At 30-days there was no aneurysmal growth and no deaths. Follow-up imaging showed endoleaks in 39 (41.9%) patients. (type 1:8, type 2:29, type 3:2).

Conclusion: The results from the PUCCINI trial demonstrate that the use of a low profile endoprosthesis for treatment of infrarenal AAA with percutaneous closure has a high rate of technical success and low rates of periprocedural complication.